Endoscopic instruments

ABSTRACT

An endoscopic instrument used to form an artificial valve for treating gastroesophageal reflux disease (GERD).

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication to Yoshia Onuki et al, entitled “Endoscopic Instruments,”application No. 60/281,016 filed Apr. 4, 2001.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to apparatuses for forming anartificial valve to treat gastroesophageal reflux disease (GERD).

[0004] 2. Description of the Related Art

[0005] The incidence of GERD has increased recently. The main symptomsof GERD are heartburn and mucosal breaks in the esophagus. Although itis a benign disease, GERD is accompanied by serious pain, and oftenrequires treatment. The main cause of GERD is decreased function of thelower esophageal sphincter (LES) at the bottom of the esophagus followedby reflux of acid into the esophagus. GERD is usually treated byadministration of acid secretion controlling agent such as proton-pumpinhibitor. Moderate GERD will improve and may be treated completely bymedication. If, however, the LES function is damaged seriously or ifanatomic problems such as hiatal hernias exist, treatment withmedication is less effective, and becomes costly over an extended periodof time.

[0006] Therefore, cases of serious GERD are often treated surgically.Effective surgical methods—including Nissen fundoplication or Toupetmethod—are known and applied widely. With this method, the LES iswrapped by the stomach wall to improve its function. This method hasbeen proven highly effective. Recently, laparoscopic surgery techniqueswere used with this method as a less invasive treatment. Because thereare many patients, and GERD is a benign disease, these less invasivetreatments are most desirable.

[0007]FIG. 39 depicts a tool for transoral treatment of GERD, disclosedin U.S. Pat. No. 5,887,594. This instrument (a) comprises a piercingdevice (e) having an elongate portion (b), a manipulation section (c)and a hook portion (d); and a securing device (i) having a connector(f), a manipulation section (g) and a securing mechanism (h). Thepiercing device (e) is inserted from the mouth to the stomach of apatient, and pulled up to the esophagus (k), with the hook portion (d)fixed at the upper stomach (j) thereby forming a fold of tissue (notshown).

[0008] Then, the securing device (i) an inserted into the esophagus (k)of the patient, and the securing mechanism (h) fixes the fold consistingof the upper stomach (j) and the esophagus (k). When the fold is fixed,the intermediate portion is compressed to inward to form valve (notshown).

[0009] FIGS. 40 to 44 depict another transoral treatment method of GERD,disclosed in International Patent Publication WO99/22649. An instrument(n) has a rotatable fastener head (p), which is rotatable at the distalend of a flexible tube (o), and the rotatable fastener head (p) andportion of the flexible tube (o) that can touch the rotatable fastenerhead (p) have a male fastener (q) and a female fastener (r),respectively. The flexible tube (o) has a rotatable grasper (s) at thedistal end, and an opening of an endoscope (t) to be inserted throughoutthe flexible tube (o). First, the flexible tube (o) is inserted from themouth to the stomach of the patient. The rotatable grasper (s) is drawninto contact with a junction (v) between the stomach and the esophagus.The rotatable grasper (s) is operated to hold the junction (v). Next,the flexible tube (o) is advanced downward to suspend the junction (v).The rotatable fastener head (p) is operated to penetrate the junction(v) with the male fastener (q) to engage with the female fastener (r).Thus, the junction (v) and the middle part (w) are compressed to beprotruded inward to form a protrusion (x).

[0010] In the composition disclosed in U.S. Pat. No. 5,887,594, the hookportion d of the piercing device (e) needs to be fixed to the stomachand pulled. The gastric wall, however, is thicker than the esophagus,and is divided into three regions: the inner mucous membrane; the middleproper muscularis; and the outer serous membrane. In particular, a spacebetween the mucous membrane and the proper muscularis has highmovability. To form a protrusion into a valve, tissue including theproper muscularis should be compressed and lifted up. The hook portion(d) only takes the mucous membrane and cannot include the propermuscularis below it. Thus, the valve formed in this application is notlarge and thick enough to prevent reflux satisfactorily.

[0011] In the apparatus disclosed in International Patent PublicationWO99/22649, the rotatable grasper (s) is integral to the flexible tube(o), which makes it difficult to touch the target tissue. The field ofview of the endoscope (t) is blocked by the rotatable fastener head (p),which makes difficult for the rotatable grasper (s) to hold and suspendthe junction (v) between the stomach and the esophagus.

[0012] Because the position between the rotatable grasper (s), the malefastener (q) and the female fastener (r) is fixed, the size of aprotrusion (x) is limited. It is desirable, however, to form aprotrusion of varying size depending on the degree of severity of GERD.The difficulty of passing food has already been reported as complicationof artificial cardia in Nissen fondoplication, and is likely to happenwith an excessively large protrusion (x). Even much smaller protrusion(x) is effective for the treatment of the moderate GERD. With thisapparatus, treatment is not flexible enough to allow a small protrusionto facilitate food flow in the case of moderate GERD. And further, themale fastener (q) is exposed outside the device, and may damage a bodylumen when it is introduced into it.

SUMMARY OF THE INVENTION

[0013] The first object of the present invention is to provide theapparatus for forming a protrusion including the proper muscularis belowthe mucous membrane to prevent gastroesophageal reflux effectively.

[0014] The second object of the present invention is to provide theapparatus for forming a protrusion that is easy to operate and willtreat in a short time.

[0015] The third object of the present invention is to provide theapparatus for holding and suspending the esophagogastric junction usinga fixing device extending out of the distal end of an endoscope toimprove the ease of the operation for forming the protrusion.

[0016] The fourth object of the present invention is to provide theapparatus for forming a protrusion of varying size by using a separateholding device and a piercing means to achieve the flexible treatmentmethod, which may be modified due to the degree of GERD severity.

[0017] The fifth object of the present invention is to provide theapparatus for forming a protrusion safely without damaging a human body.

[0018] In accordance with the present invention, a tissue-piercingdevice, to be used with an endoscope, which has two piercing memberswhich have a needle, also includes two slidable suture-holding meanswhich are inserted in the each needle and are extended from or retractedinto the distal ends of the needles, and at least a holding-operationmeans for operating the suture-holding means.

[0019] The tissue-piercing device may also include two slidable sutureswhich are inserted in each needle.

[0020] It may also include a slidable suture-holding means which isinserted in one needle and is extended from or retracted into the distalend of the needle, and a holding-operation means for operating thesuture-holding means, and a slidable suture inserted in the otherneedle. It is possible for the suture-holding means to hold the suture.

[0021] The present invention is also directed to a treatment systemcomprising first and second endoscopes to be inserted orally into ahuman body; a tissue-piercing device according to the present inventionbeing mounted to the first endoscope; a tissue-fixing device extendingout of the distal end of the second endoscope and fixed at a piercingpoint, and a suture which is folded in a U shape and inserted into ahuman body using the second endoscope.

[0022] A tissue-piercing device with two slidable sutures according tothe present invention may be mounted to the first endoscope; atissue-fixing device extending out of the distal end of the secondendoscope and fixed at a piercing point, and a holding means for asuture which is inserted into a human body using the second endoscope.

[0023] A tissue-piercing device with slidable suture-holding meansaccording to the present invention may be mounted to the firstendoscope; and a tissue-fixing device extending out of the distal end ofthe second endoscope and fixed at a piercing point.

[0024] In the tissue-piercing device according to the present invention,the two needles may be parallel and apart from each other.

[0025] There may also be operation sections at the proximal ends of thepiercing members; a distal coupling member for connecting distal ends ofthe needles; and a proximal coupling member for connecting the operationsections of the piercing members.

[0026] The distal coupling member may be formed to be mounted to thedistal end of the endoscope, and the proximal coupling member may beformed to be mounted to the operation section of the endoscope. Thedistal coupling member may be a cap which may be made of transparentmaterial.

[0027] In the tissue-piercing device according each piercing member mayinclude a flexible outer sheath, a slidable flexible inner sheath whichis inserted in the outer sheath and is extended from or retracted intothe distal end of the outer sheath, a slidable needle which is insertedin the inner sheath and is extended from or retracted into the distalend of the inner sheath, a housing to be connected to the proximal endof the outer sheath, an inner sheath operation means connected to theproximal end of the inner sheath for moving back and forth the innersheath, and a needle operation means connected to the proximal end ofthe needle for moving back and forth the needle.

[0028] The tissue-piercing device may also include a switch means forswitching between a two-piercing member operation and a separateoperation.

[0029] A switch means for switching between a two-needle/inner sheathoperation and a separate operation may also be provided. When the switchmeans selects a two-needle operation, the needle extension may be variedto allow piercing the tissue with one needle after another

[0030] The suture-holding means may be loop-shaped.

[0031] A driving member for rotating or moving back and forth thesuture-holding means may be provided at the proximal end of thesuture-holding means, and the central axis of the suture-holding meansmay be inclined against the longitudinal axis of the driving member.

[0032] The tissue-piercing device, to be used with an endoscope, mayinclude a delivery means for delivering a knot of the suture into thetarget site in the human body and tightening it.

[0033] The delivery means may comprise at least one hole.

[0034] The cap may have at least a side hole which performs as deliverymeans for delivering a knot of the suture formed outside the human bodyinto it.

[0035] The present invention is also directed to a tissue-fixing device,to be used with an endoscope, which comprises a delivery means fordelivering a knot of the suture into the target site in the human bodyand tightening it.

[0036] It is also directed to a knot pusher, to be used with anendoscope, comprising a pair of opening or closing jaws; and a hole madein each jaw. The jaws may also serve as a means for fixing tissue.

[0037] The endoscope may be a flexible endoscope and embodiments of thepresent invention may be used to suture tissue in the human body. Inparticular, embodiments of the present invention may be used to form anartificial valve for treating gastroesophageal reflux disease (GERD).

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] First Embodiment (FIGS. 1 to 20, 29)

[0039] Description of a Piercing Device and a Knot Pusher (FIGS. 1 to7,10, 29)

[0040] A piercing device 1 comprises a main body 2, inner sheaths 3 aand 3 b, needles 4 a and 4 b, an inner sheaths-coupling member 5, and aneedles-coupling member 6.

[0041] The main body 2 comprises two outer sheaths 7 a and 7 b, caps 8connected at the distal ends of the sheaths 7 a and 7 b, and anoperation section 9 connected at the proximal end of the sheaths 7 a and7 b.

[0042] The cap 8 comprises an outer sheaths-connecting section 10, adistal cylindrical section 11, and a distal mounting section 12.

[0043] The distal cylindrical section 11 is made of a relatively hardmaterial. Preferably, it is made of a transparent plastic material suchas polycarbonate lest it should obstruct the vision of a first endoscope27. Preferably, the inner diameter is about 5 to 15 mm, the wallthickness is about 1 mm. The length is about 3 to 10 mm, and a shortercylinder is better. Side holes 13 a and 13 b are positioned at theopposite sides, apart 180 degrees each other. The side holes 13 a and 13b are responsible for pushing a knot of a suture, and the piercingdevice 1 itself acts as a knot pusher. A suture (which will be describedlater) pass through the side holes 13 a and 13 b, which each have aninner diameter of preferably about 1 mm.

[0044] The distal mounting section 12 is cylindrical and is inserteddetachably to the distal end of the first endoscope 27. The firstendoscope is flexible endoscope. The distal mounting section 12 is madeof a relatively soft plastic material such as PVC or other thermoplasticelastomer. Its inner diameter depends on the size of the distal end ofthe endoscope to be used and is generally about 10 mm.

[0045] The outer sheaths-connecting section 10 has a ring section fixedover the periphery of the distal cylindrical section 11, and connectionlegs 14 a and 14 b which are extending longitudinally and axially,parallel with each other. The connection legs 14 a and 14 b arepreferably positioned at opposite sides and 180 degrees apart from oneanother. The connection legs 14 a and 14 b are preferably apart by 10 to20 mm, depending on the outer diameter of the distal cylindrical section11.

[0046] The connection legs 14 a and 14 b have penetration holes and formopenings 15 a and 15 b at the distal end.

[0047] The outer sheaths 7 a and 7 b are hollow and flexible enough tofollow the curvature of the first endoscope 27. For example, they areplastic tubes made of fluoroplastics, polyethylene, polyamide,polyimide, polyurethane or other thermoplastic elastomer, or metalcoils. They may be metal coils covered by plastic tubes. They may beplastic tubes with metal mesh to prevent kink. The inner diameter isabout 1 to 2 mm, the outer diameter is about 1.5 to 3 mm, and the lengthis about 1 to 1.5 m. The distal ends of the outer sheaths 7 a and 7 bare fixed to the connection legs 14 a and 14 b and are in parallelpositions. The openings 15 a and 15 b are connected and communicatedwith the lumen of the outer sheaths 7 a and 7 b.

[0048] The operation section 9 comprises a base 16, grips 17 a and 17 b,sliders 18 a and 18 b, a proximal mounting section 20, and a channelport 21. The proximal ends of the outer sheaths 7 a and 7 b penetratethe base 16 and are connected to the distal ends of the grips 17 a and17 b.

[0049] The grips 17 a and 17 b are cylindrical, and have screws 24 a and24 b on the periphery of the proximal ends with which slider locks 22 aand 22 b are engaged. Between the screws 24 a and 24 b and the sliderlocks 22 a and 22 b, there are elastic tubular fixing rings 23 a and 23b made of rubber such as silicon rubber or fluorine rubber, orthermoplastic elastomer. Sliders 18 a and 18 b are positioned slidablyinside the fixing rings 23 a and 23 b. When the slider locks 22 a and 22b are tightened, the fixing rings 23 a and 23 b are pressedlongitudinally and expanded radially to immobilize the sliders 18 a and18 b.

[0050] The sliders 18 a and 18 b are cylindrical. They are comprised ofslider stoppers 25 a and 25 b at the proximal end for limiting a slidingarea against the grips 17 a and 17 b, slider port 19 a and 19 b, andnarrow sections 26 a and 26 b for connecting the inner sheaths-couplingmember 5.

[0051] The proximal mounting section 20 is mounted at the distal end ofthe base 16, and is fixed detachably to a forceps channel port 28 of thefirst endoscope 27.

[0052] The channel port 21 is mounted to the proximal end of the base16, and is plugged detachably with a forceps valve 29. The channel port21 is connected through the lumen of the proximal mounting section 20and the lumen in the base 16 to the forceps channel (not shown) of thefirst endoscope 27.

[0053] The inner sheath 3 a or 3 b comprises an inner sheath port 30, aninner sheath pipe 31, an O ring 32, and a sheath section 33. The innersheath 3 a or 3 b can be inserted via the slider port 19 into the outersheath 7.

[0054] When the inner sheath 3 is inserted to the outer sheath 7, theinner sheath port 30 is connected detachably to the slider port 19. Theinner sheath port 30 has a lumen.

[0055] The inner sheath pipe 31 is connected to the sheath section 33and the inner sheath port 30. The lumen of the inner sheath pipe 31 isalso communicated with the lumen of the sheath section 33 and the lumenof the inner sheath port 30.

[0056] The O ring 32 is held between the proximal end of the innersheath pipe 31 and the inner sheath port 30. It is made of elasticrubber such as silicon rubber or fluororubber, or thermoplasticelastomer. It is received in grooves 66 a and 66 b of a needle body 34of the needle 4, which is described later, and stops movement of theneedle body 34.

[0057] The sheath section 33 is hollow and flexible enough to follow thecurvature of the first endoscope 27. For example, it is a plastic tubemade of fluoroplastics, polyethylene, polyamide, polyimide, polyurethaneor other thermoplastic elastomer, or a metal coil. It may be a plastictube with metal mesh to prevent kink. The inner diameter is about 0.5 to1.5 mm, and the outer diameter is about 1 to 2.5 mm.

[0058] When the slider 18 slides against the grip 17, The sheath section33 slides in the outer sheath 7. The length of the inner sheath 3 isadjusted so that the distal end of the sheath section 33 is positionedproximal to the opening 15 when the slider 18 is pulled completely fromthe grip 17, and the distal end of the sheath section 33 is positioneddistally about 15 to 50 mm from the opening 15 of the cap 8 when theslider 18 is pushed sufficiently to touch the grip 17.

[0059] The needle 4 a or 4 b comprises a needle body 34, a needle grip35, and suture-holding forceps 38 inserted in them. The needle 4 a or 4b can be inserted through the inner sheath port 30 into the inner sheath3.

[0060] The needle body 34 is a metal pipe made of stainless steel ornitinol, which is resistant to pressure from the proximal end duringpiercing and flexible enough to follow the curvature of the firstendoscope 27. The inner diameter is about 0.5 mm and the outer diameteris about 1 mm.

[0061] To facilitate projection of the distal end of the needle body 34out of the distal end of the inner sheath 3, the outer diameter of theneedle body 34 preferably approximates the inner diameter of the innersheath 3. The proximal end of the needle body 34 is connected a portbody 36 of the needle grip 35. The needle body 34 has two grooves 66 aand 66 b near the proximal end.

[0062] The needle body 34 slides in the inner sheath 3 by needle grip 35moving back and forth against the inner sheath port 30. When the 0 ring32 of the inner sheath 3 is engaged in the groove 66 a, the distal endof the needle body 34 is positioned slightly proximal than the distalend of the sheath section 33, and when the 0 ring 32 is engaged in thegroove 66 b, the distal end of the needle body 34 extends out of thedistal end of the sheath section 33. Preferably, the needle body 34extends out of the distal end of the sheath section 33 by about 50 to 70mm. Preferably, the distal ends of the needle bodies 34 a and 34 bshould be apart by at least 10 mm when the needle bodies 34 a and 34 bextend out of the distal ends of the sheath sections 33 a and 33 b.

[0063] The needle grip 35 comprises a port body 36, a needle port 37,and a elastic cylindrical fixing ring 42 between them made of rubbersuch as silicon rubber or fluororubber, or thermoplastic elastomer.

[0064] The port body 36 and the needle port 37 have lumen and areconnected with screws. An operation pipe 40 of the suture-holdingforceps 38 slides in the lumen. When the needle port 37 is tightened,the fixing ring 42 is pressed longitudinally and expanded radially tofix the operation pipe 40. The needle port 37 also has a narrow section43 to which the needles-coupling member 6 is connected.

[0065] The suture-holding forceps 38 is inserted in advance into theneedle body 34 and the needle grip 35 for sliding. The suture-holdingforceps 38 has a loop shaped holding section 41 at the distal end of theoperation pipe 40. The holding section 41 is a metal wire made ofstainless steel or nitinol, or plastic wire. The wire may be a singlewire or a stranded wire. It has the diameter, which allows retractingthe holding section 41 into the needle body 34. The holding section 41is adjusted to open by 10 to 20 mm when it extends out of the needlebody 34.

[0066] The holding section 41 can be of any loop shape. It may be like abasket forceps.

[0067] The operation pipe 40 extends from the proximal end of theholding section 41 to the proximal end of the needle port 37. Theoperation pipe 40 is connected an operation knob 39 at the proximal end.The operation pipe 40 is a slim metal pipe for smooth rotation such asstainless steel or nitinol. The holding section 41 is rotated followingthe rotation of the operation knob 39.

[0068] The inner sheaths-coupling member 5 can be mounted to the narrowsections 26 a and 26 b of the sliders 18 a and 18 b detachably.

[0069] The inner sheaths-coupling member 5 is an elastic yet relativelyhard plastic sheet. There are two slits 44 a and 44 b on one side, whichare connected to coupling holes 45 a and 45 b.

[0070] The width of the slits 44 a and 44 b are slightly narrower thanthe outer diameter of the narrow sections 26 a and 26 b of the sliders18 a and 18 b. The inner diameter of the coupling holes 45 a and 45 b isnearly equal to the outer diameter of the narrow sections 26 a and 26 b.The each distance between the slits 44 a and 44 b, or coupling holes 45a and 45 b is equal to the distance between the narrow sections 26 a and26 b. When the slits 44 a and 44 b are pressed to the narrow sections 26a and 26 b, the slits 44 a and 44 b open to connect the coupling holes45 a and 45 b with the narrow sections 26 a and 26 b. To remove theinner sheaths-coupling member 5, the narrow sections 26 a and 26 b arepulled out of the slits 44 a and 44 b.

[0071] When the inner sheaths-coupling member 5 is mounted to thesliders 18 a and 18 b, both inner sheaths 3 a and 3 b can be moved backand forth at one time either by holding and moving one slider 18 or theinner sheaths-coupling member 5. The inner sheaths 3 a and 3 b extend bythe same length out of the openings 15 a and 15 b.

[0072] To change the extension length of either inner sheath 3 a or 3 b,the inner sheaths-coupling member 5 is removed, and the sliders 18 a and18 b are operated separately.

[0073] The needles-coupling member 6 and the inner sheaths-couplingmember 5 are similarly composed. The needles-coupling member 6 can bemounted to the narrow section 43 a and 43 b of the needle ports 37 a and37 b detachably. According to mounting and removing the needles-couplingmember 6, the needles 4 a and 4 b are operated at one time orseparately. When the separate operation is selected, the extensionlength of the needles 4 a and 4 b out of the distal end of the innersheath 3 a or 3 b may be varied.

[0074] Description of the Fixing-Holding Forceps and a Suture (FIGS. 8and 9)

[0075] The fixing-holding forceps 46 comprises a distal section 47, anelongate sheath 48 fixed at the proximal end of the distal section 47and inserted in a forceps channel 58 of a flexible second endoscope 57,and an operation section 49 fixed detachably at the proximal end of thesheath 48 for operating the distal section 47.

[0076] The distal end section 47 has a pair of jaws 59 a and 59 b. Theoperation section 49 has a slider handle 50. An operation cable (notshown) connects the jaws 59 a and 59 b with the slider handle 50. Thejaws 59 a and 59 b are opened or closed by moving the slider handle 50back and forth.

[0077] The proximal end of the sheath 48 with the operation section 49detached, is inserted from the distal opening of the forceps channel 58through a forceps channel port 60. The operation section 49 is thenmounted, and the fixing-holding forceps 46 is set on the secondendoscope 57.

[0078] A suture cartridge 52 is inserted movably in the lumen of anouter channel 51 fixed on the outer periphery of the second endoscope57.

[0079] The suture cartridge 52 comprises a hollow and flexible cartridgetube 53, and a suture placed in the hollow lumen. The cartridge tube 53is made of plastic material such as fluoroplastics or polyethylene. Thecartridge tube 53 is preferably made of relatively transparent materialsuch as fluoroplastics so that the movement of the suture 54 isrecognized easily in an endoscopic image.

[0080] The suture 54 is bent at the proximal end of the cartridge tube53 and is stored, movably, in a U-shape in the cartridge tube 53. Thefold 56 is exposed out of the proximal end of the cartridge tube 53.Suture ends 55 a and 55 b are exposed out of the distal end of thecartridge tube 53. At that point, the suture ends 55 a and 55 b arepositioned so that one is 5 to 10 mm in front of the other. The suture54 is a general surgical suture made of, for example, nylon or silk. Thesuture 54 is 0.2 to 0.5 mm thick, and preferably 0.3 to 0.4 mm thick.The suture ends 55 a and 55 b are preferably colored differently foreasy recognition: A part from the suture end 55 a to the fold 56 iscolored differently from a part from the suture end 55 b to the fold 56,and the two parts are welded at the fold 56.

[0081] Mounting the Device to an Endoscope (FIGS. 8 and 10)

[0082] The piercing device 1 is mounted in the following procedure.

[0083] The proximal mounting section 20 is mounted to the forcepschannel port 28 of the first endoscope 27. The distal mounting section12 of the cap 8 is inserted to the distal end of the first endoscope 27while the outer sheaths 7 a and 7 b are held lest they should betwisted. The outer sheaths 7 a and 7 b are fixed at several points onthe outer periphery of the first endoscope 27 with surgical tape.

[0084] The inner sheaths 3 a and 3 b are inserted through the sliderports 19 a and 19 b to the outer sheaths 7 a and 7 b, and the innersheath port 30 a and 30 b are connected and fixed to the slider ports 19a and 19 b.

[0085] With the suture-holding forceps 38 a and 38 b placed completelyinto the needle bodies 34 a and 34 b, the needles 4 a and 4 b areinserted through the inner sheath ports 30 a and 30 b into the innersheaths 3 a and 3 b. The groove 66 a of the needle bodies 34 a and 34 bshould be engaged with the O ring 32 of the inner sheaths 3 a and 3 b.The needle bodies 34 a and 34 b are then positioned so as not to extendout of the distal ends of the sheath sections 33 a and 33 b.

[0086] The sliders 18 a and 18 b are pulled proximally. The sheathsections 33 a and 33 b are pulled in the outer sheaths 7 a and 7 b inadvance so that the distal ends of the sheath sections 33 a and 33 b arepositioned more proximally than the openings 15 a and 15 b.

[0087] The fixing-holding forceps 46 is mounted to the second endoscope57 in advance.

[0088] Holding and Pulling Down the Cardia (FIG. 11)

[0089] The sheath 48 of the fixing-holding forceps 46 is pulledproximally and retained in a position in which the distal section 47preferably does not extend out of the distal end of the second endoscope57. The second endoscope 57 is inserted into the patient's body,advanced to the stomach, and inverted to look up the cardia 61 forobservation.

[0090] Next, the slider handle 50 is pushed out against the operationsection 49 distally to open the jaws 59 a and 59 b. The sheath 48 issent toward the distal end, and the jaws 59 a and 59 b are brought intocontact with tissue of the greater curvature 62 of the cardia 61. Theslider handle 50 is then pulled proximally to close the jaws 59 a and 59b and hold and fix the tissue 62.

[0091] The second endoscope 57 and the fixing-holding forceps 46 arepressed together into the patient's body and pulled down while thetissue 62 is held and fixed between the jaws 59 a and 59 b.

[0092] When a valve to be formed is not so large, the cardia may not beheld and pulled down by the fixing-holding forceps 46.

[0093] Penetrating the Stomach and the Esophagus Using a PenetrationNeedle (FIGS. 11 and 12)

[0094] The first endoscope 27 is inserted parallel to the secondendoscope 57.

[0095] The distal end of the first endoscope 27 is positioned at anupstream point 63 of the esophagogastric junction while they areobserved. The distal end of the first endoscope 27 is inclined slightlytoward the greater curvature of the stomach. The sliders 18 a and 18 bare moved against the grips 17 a and 17 b to the distal end. The sheathsections 33 a and 33 b are extended out of the openings 15 a and 15 band pressed against the entering points 64 a and 64 b. Depending on thecondition and form of the body lumen, the inner sheaths-coupling member5 is either attached to the narrow sections 26 a and 26 b to press thesheath sections 33 a and 33 b at one time, or is removed to press thesheath sections 33 a and 33 b separately.

[0096] After the sheaths sections 33 a and 33 b are pressed, the sliderlocks 22 a and 22 b are tightened to the grips 17 a and 17 b to fix thesliders 18 a and 18 b.

[0097] The needle grips 35 a and 35 b are pressed toward the distal enduntil the groove 66 b of the needle bodies 34 a and 34 b is engaged withthe O ring 32, and the needle bodies 34 a and 34 b are extended out ofthe sheath sections 33 a and 33 b.

[0098] The needles-coupling member 6 is either attached to the narrowsections 43 a and 43 b to press the needle bodies 34 a and 34 b at onetime, or is removed to press the needle bodies 34 a and 34 b separately.Pressing the needle bodies 34 a and 34 b at one time makes operationeasy, but increases penetration resistance of the needles and requiresmore force to penetrate them into tissue. On the other hand, pressingthe needle bodies 34 a and 34 b separately makes it easy to penetratethe tissue, but requires two rounds of penetration procedures.

[0099] When the needle bodies 34 a and 34 b are extended out of thesheath sections 33 a and 33 b, they pass through the entering points 64a and 64 b of the esophageal wall 67, the exiting points 65 a and 65 bof the stomach wall 68 near the cardia and enter the stomach.

[0100] The second endoscope 57 is used to check that the needle bodies34 a and 34 b enter the stomach.

[0101] Inserting a Suture to Tissue (FIGS. 13 to 16)

[0102] The suture cartridge 52 is inserted into the outer channel 51 andextended into the stomach while it is observed by the second endoscope57. The operation knob 39 a of the needle 4 a is pressed toward thedistal end and the holding section 41 a is extended out of the distalend of the needle body 34 a.

[0103] Either the suture cartridge 52 or the suture 54 is advanced orretreated to insert the suture end 55 a into the holding section 41 a.

[0104] Because the holding section 41 a is synchronized and rotated withthe operation knob 39 a, it is easy to insert the suture end 55 a intothe holding section 41 a.

[0105] The operation knob 39 a is pulled proximally to pull the holdingsection 41 a into the needle body 34 a and hold the suture end 55 a.

[0106] The needle port 37 a of the needle grip 35 a is tightened to theport body 36 a to lock the holding section 41 a and the suture end 55 a.

[0107] Similarly, the suture end 55 b is held by the holding section 41b.

[0108] Since the holding sections 41 a and 41 b are loop shape, they canprevent that the suture 54 slips from the holding sections 41 a and 41b. As a result, it is easy to hold the suture 54 by the holding sections41 a and 41 b.

[0109] The needle grips 35 a and 35 b are then pulled back proximallyand the distal ends of the needle bodies 34 a and 34 b are pulled intothe sheath sections 33 a and 33 b. The suture ends 55 a and 55 bpenetrate the gastric wall 68 and the esophageal wall 67 and reach tothe upstream point 63 of the esophagogastric junction.

[0110] The slide locks 22 a and 22 b are loosened, and the grips 18 aand 18 b are pulled back proximally to pull the distal ends of thesheath sections 33 a and 33 b in the outer sheaths 7 a and 7 b. Thefirst endoscope 27 is then removed from the patient's body. The suture54 is drawn out of the cartridge tube 53.

[0111] After the first endoscope 27 and the piercing device 1 areremoved from the patient's body, the operation knobs 39 a and 39 b arepressed toward the distal end to extend the holding sections 41 a and 41b out of the outer sheaths 7 a and 7 b, and remove the suture ends 55 aand 55 b out of the holding sections 41 a and 41 b.

[0112] The suture ends 55 a and 55 b are pulled further to bring thefold 56 into contact with the inner surface of the gastric wall 68.

[0113] The slider handle 50 of the fixing-holding forceps 46 is thenmoved toward the distal end to open the jaws 59 a and 59 b and releasethe tissue 62. The second endoscope 57 is removed together with thefixing-holding forceps 46 and the cartridge tube 53.

[0114] Fixing the Suture and Forming an Artificial Valve (FIGS. 17 to19)

[0115] The suture ends 55 a and 55 b are tied outside the patient's bodyto form a knot 69.

[0116] If the knot 69 is a so-called square knot as shown in FIG. 17,the suture ends 55 a and 55 b are inserted into the side holes 13 a and13 b at the distal cylindrical section 11 of the cap 8.

[0117] If the knot 69 is a so-called Roeder knot as shown in FIG. 18,only one suture end 55 a is inserted into the side hole 13 a or 13 b.

[0118] The suture ends 55 a and 55 b are inserted in a way that theypass the inner to the outside of the distal cylindrical section 11.

[0119] The first endoscope 27 is advanced into the patient body whilethe suture ends 55 a and 55 b are held and pulled.

[0120] The knot 69 is advanced by the distal cylindrical section 11 ofthe cap 8 as the first endoscope 27 is inserted. The knot 69 can beobserved by the first endoscope 27.

[0121] When the knot reaches near the entering points 64 a and 64 b ofthe esophagus, the distal cylindrical section 11 is pressed against theesophageal wall 67, while the suture ends 55 a and 55 b are pulled tolock the knot 69.

[0122] The above procedure is repeated several times before it ischecked that the knot 69 is tied firmly. Then the first endoscope 27 andthe piercing device 1 are removed from the patient's body.

[0123] As a result, the gastric wall near the exiting points 65 a and 65b is brought close to the entering points 64 a and 64 b. Theesophagogastric junction 70 between the exiting points 65 a and 65 b andthe entering points 64 a and 64 b are contracted to form an inwardprojection 71.

[0124] Finally, excess sutures beyond the knot 69 are cut usingendoscopic scissors, and are collected outside the body to finish thetreatment.

[0125] The fixing-holding forceps 46 inserted in the second endoscope 57allow pulling the tissue 62 while it is held and fixed. The jaws 59 aand 59 b are brought into contact with the tissue 62 under observationusing the second endoscope 57, which simplifies operation and shortensits time.

[0126] Because the first endoscope 27 and the piercing device 1 whichare operated separately from the second endoscope 57 and thefixing-holding forceps 46 are provided, the pulling amount of the cardiaor the position of the entering point 64 can be determined at anoperator's discretion to form a valve of any size, depending on thecondition of a particular patient.

[0127] The piercing device 1 incorporates two penetration needles inadvance, so once the distal end of the first endoscope 27 approaches apenetration point of the esophageal wall 67, two needles can bepenetrated immediately. This also means easy operation and reduced time.

[0128] The piercing device 1 has the sheath sections 33 a and 33 b andthe distal end of them can be touched body tissue before shooting theneedle bodies 34 a and 34 b. It makes it easy to locate the penetrationpoint and reliably penetrates toward the inside of the stomach throughthe esophagogastric junction 70. If a larger valve is not required, sucha valve can be formed with no tissue 62 held and fixed by thefixing-holding forceps 46. It simplifies operation and shortens thetime.

[0129] The piercing device 1 has two penetration needles in parallel, sothe entering points 64 a and 64 b and the exiting points 65 a and 65 bare set apart a desired distance. As a result, an area of the bodytissue to be contracted by the suture is not small but still largeenough to form a valve of desired size.

[0130] The outer sheaths 7 a and 7 b which receive the needles 4 a and 4b are attached to the cap 8 at a desired position. Only by attaching thecap 8 to the distal end of the first endoscope 27, can the distal endsof the outer sheaths 7 a and 7 b be mounted easily to the distal end ofthe first endoscope 27 at a specified position. This shortens the timerequired for mounting to the endoscope.

[0131] The side holes 13 a and 13 b on the cap 8 are capable of holdingand pushing the knot of the suture. It is not necessary to prepare aknot pusher for holding and pushing the knot, which decreases medicalcosts and eliminates the need for another tool.

[0132] The needles 4 a and 4 b can be housed in the inner sheaths 3 aand 3 b and the outer sheaths 7 a and 7 b. The piercing device 1 isinserted into a body lumen without damaging it.

[0133] Second Embodiment (FIGS. 21 to 27)

[0134] Only points which are different from those of the firstembodiment are described.

[0135] A piercing device 101 is the piercing device 1 with its needles 4a and 4 b replaced by needles 102 a and 102 b.

[0136] The needle 102 comprising a needle body 34, a needle grip 104connected proximal to the needle body 34, and a suture 103 insertedmovably in the needle body 34 and the needle grip 104. The needle grip104 has a narrow section 43 to which the needles-coupling member 6 isconnected.

[0137] The lumen in the outer channel 51 fixed on the outer periphery ofthe second endoscope 57 has suture-holding forceps 105 which areinserted movably.

[0138] The suture-holding forceps 105 comprise a flexible sheath 107, anoperation section 108 which is rotated against and connected proximal tothe flexible sheath 107, a handle 109 which slides against the operationsection (108), a driving member 110 which is connected at the distal endof the handle 109 and extended slidably in the sheath 107, and a holdingsection 106 connected at the distal end of the driving member 110. Theholding section 106 is extended out or withdrawn into the distal end ofthe sheath 107 by moving the handle 109 back and forth.

[0139] The holding section 106 can be of any loop shape, for example,snare forceps or basket forceps. The holding section 106 is a metal wiremade of stainless steel or nitinol, or a plastic wire. The wire can be asingle wire or strand wire. The wire is thick enough to pull the holdingsection 106 into the sheath 107. The holding section 106 is so sized asto open by 10 to 30 mm when it is extended out of the sheath 107.

[0140] The holding section 106 is bent and mounted to the driving member110 so that the central axis 111 of the loop forming the holding section106 inclines against the longitudinal direction of the driving member110.

[0141] The driving member 110 is made of a metal wire that follows anyrotation. The holding section 106 rotates following the operationsection 108.

[0142] After the needle bodies 34 a and 34 b of the piercing device 101mounted to the first endoscope 27 pierce the esophageal wall 67 and thegastric wall 68, the suture-holding forceps 105 are inserted into theouter channel 51 fixed on the outer periphery of the second endoscope 57to introduce the distal end of the sheath 107 in the stomach underobservation using the second endoscope 57.

[0143] The handle 109 is pressed toward the distal end to extend theholding section 106 out of the sheath 107.

[0144] The sheath 107 is moved back and forth, or the operation section108 is rotated, to rotate the holding section 106 and position it justbelow the needle bodies 34 a and 34 b. The sutures 103 a and 103 binserted in the needles 102 a and 102 b are pressed and inserted in theloop of the holding section 106.

[0145] The handle 109 is then pulled proximally to pull the holdingsection 106 in the sheath 107 and hold and fix the suture ends 112 a and112 b of the sutures 103 a and 103 b.

[0146] The suture-holding forceps 105 are removed from the outer channel51 while fixing the suture ends 112 a and 112 b.

[0147] The holding section 106 is opened again to remove the suture ends112 a and 112 b. They are tied to form a knot 113, and the excesssutures are cut off. The sutures 103 a and 103 b exposing proximallybeyond the needle grip 104 a and 104 b of the needles 102 a and 102 bare pulled to pull the knot 113 back into the patient's body. The knot113 should touch near the exiting points 65 a and 65 b of the stomach.

[0148] In addition to the effect of the first embodiment, because theholding section 106 of the suture-holding forceps 105 holds the sutureends 112 a and 112 b at one time, suture-holding operations using thesuture-holding forceps in the body are halved, simplifying operation andreducing time.

[0149] Third Embodiment (FIGS. 28 and 30)

[0150] Only points which are different from those of the firstembodiment are described.

[0151] The suture-holding forceps 121 of the needle 120 have a holdingsection 122 at the distal end of the operation pipe 40. The holdingsection 122 is bent and mounted to the operation pipe 40 so that thecentral axis 123 of the loop 124 forming the holding section 122inclines against the longitudinal axis of the operation pipe 40.

[0152] When the holding section 122 is rotated, the loop 124 forming theholding section 122 is moved in an area 125 larger than that of thefirst embodiment.

[0153] Because the loop 124 forming the holding section 122 moves in alarger area, the suture-end is inserted into the loop 124 easily forimproved operability and shortened time.

[0154] Fourth Embodiment (FIGS. 31 to 33)

[0155] Only points which are different from those of the firstembodiment are described.

[0156] A piercing device 140 is the piercing device 1 with one of theneedles 4 a and 4 b replaced by the needle 102 in the second embodiment,and the other replaced by a needle 141. The needle 102 is comprised samewith that of the second embodiment.

[0157] Suture-holding forceps 145 that extend from or retract into theneedle 141 have a holding section 142 at the distal end of the operationpipe 40. The holding section 142 is bent and mounted to the operationpipe 40 so that the central axis 143 of the loop 144 forming the holdingsection 142 inclines against the longitudinal axis of the operation pipe40.

[0158] The length L of the holding section 142 is longer than thedistance I between the two needle bodies 34 a and 34 b, and the sutureend 112 of the suture 103 extending out of the needle 102 is inserted ina loop 144 formed by the holding section 142.

[0159] The second endoscope 57 does not have the outer channel 51, andthe fixing-holding forceps 46 are inserted in a forceps channel (notshown).

[0160] After the needle bodies 34 a and 34 b of the piercing device 140which are mounted to the first endoscope 27 pierce the esophageal wall67 and the gastric wall 68, the holding section 142 of thesuture-holding forceps 145 is extended out of the needle 34 b.

[0161] The operation knob 39 is rotated while it is observed by thesecond endoscope 57 to rotate the holding section 142 until thelongitudinal axis of the needle body 34 a is positioned in the loop 144of the holding section 142.

[0162] The suture 103 in the needle 102 is pressed out, and the sutureend 112 is inserted in the loop 144.

[0163] The operation knob 39 is pulled proximally to hold the suture end112.

[0164] Next, with the suture 103 extending from the proximal end of theneedle grip 104 released, the needle grips 35 and 104 are pulled backproximally to retract the distal ends of the needle bodies 34 a and 34 binto the sheath sections 33 a and 33 b. Thus, the suture end 103penetrates the gastric wall 68 and the esophageal wall 67.

[0165] The suture is penetrated only with the piercing device 140 andanother device such as suture-holding forceps is not necessary.Preparation before treatment is simplified and does not take a longtime. Moreover, another tool is not necessary and the cost is reduced.

[0166] Because the second endoscope 57 does not require the outerchannel 51, the second endoscope 57 is narrowed and inserted into a bodylumen easily.

[0167] Fifth Embodiment (FIGS. 34 to 36)

[0168] Only points different from those of the first embodiment aredescribed.

[0169] A piercing device 150 is the piercing device 1 with theneedles-coupling member 6 replaced by a needles-coupling member 151.

[0170] The needles-coupling member 151 comprising a distal section 152,a middle section 153 and a proximal section 154, and is shaped like acrank. The distal section 152 and the proximal section 154 arepositioned longitudinally apart each other. The distal section 152should be apart from the proximal section 154 by at least the thicknessof tissue to be penetrated, or at least 5 mm.

[0171] Coupling holes 45 a and 45 b of the needles-coupling member 151are mounted via the slits 44 a and 44 b to the needle ports 37 a and 37b of the needle grips 35 a and 35 b. Because the distal section 152 andthe proximal section 154 are apart each other, the distal ends of theneedle bodies 34 a and 34 b are longitudinally apart from each other.When the needles-coupling member 151 is held and pressed toward thedistal end, the needle bodies 34 a and 34 b are extended out of theinner sheaths 33 a and 33 b with its distance between the twomaintained.

[0172] When the piercing device 150 is used for penetrating theesophageal wall 67 and the gastric wall 68, first needle body 34 apenetrates the esophageal wall 67 and the gastric wall 68; next needlebody 34 b penetrates them.

[0173] Because two needles never penetrates tissue at one time even ifthe needles coupling-member 151 is pressed to operate the two needles,penetration resistance will not be increased, and penetration is easy.

[0174] Sixth Embodiment (FIGS. 37 and 38)

[0175] Only points that are different from those of the fixing-holdingforceps 46 in the first embodiment are described.

[0176] As shown in FIG. 37(a), fixing-holding forceps 160 have a pair ofjaws 162 a and 162 b at a distal end 161 for holding tissue. The jaws162 a and 162 b have side holes 163 a and 163 b, and their distal endopenings 164 a and 164 b are positioned near the distal ends of the jaws162 a and 162 b. The side holes 163 a and 163 b are large enough to passa suture and are preferably at least 1 mm.

[0177] The fixing-holding forceps 160 can have a composition as shown inFIG. 37(b). FIG. 37(b) is a view of the distal end with the jaws 162 aand 162 b of the fixing-holding forceps 160 opened. The jaws 162 a and162 b have side holes 165 a and 165 b near the distal end. Slits 166 aand 166 b are extended from the side holes 165 a and 165 b to the sidesof the jaws 162 a and 162 b. The side holes 165 a and 165 b and theslits 166 a and 166 b are large enough to pass the suture, or preferablyat least 1 mm.

[0178] As shown in FIGS. 38(a) and (b), the suture 54 is inserted in thejaws 162 a and 162 b and the side holes 163 a and 163 b or 165 a and 165b. In the case shown in FIG. 37(b), the suture 54 is inserted throughthe slits 166 a and 166 b to the side holes 165 a and 165 b.

[0179] Then, while the suture ends 55 a and 55 b are held and pulled,the second endoscope 57 is advanced again into the body lumen.

[0180] As the second endoscope 57 is advanced, the knot 69 is alsopushed forward by the distal ends of the jaws 162 a and 162 b while itis observed under the second endoscope 57.

[0181] When the knot 69 reaches the esophageal wall 67, the jaws 162 aand 162 b open, and the suture ends 55 a and 55 b are pulled to fix theknot 69.

[0182] Opening the jaws 162 a and 162 b applies more tensile strength tothe suture 54 proximal to the knot 69, thus fixing the knot 69 firmly.This means that a formed valve is maintained reliably for a long time.

[0183] The fixing-holding forceps 160 hold a knot of the suture and donot require another knot pusher. Therefore, medical costs andpreparation time are reduced.

[0184] The outer diameter of the second endoscope 57 to which only oneouter channel 51 is mounted is smaller than that of the first endoscope27 to which two outer sheaths 7 a and 7 b of the piercing device aremounted. The fixing-holding forceps 160 attached to the second endoscopehave a means for delivering a knot of the suture to make it easy toinsert an endoscope into the body.

[0185] The above compositions achieve the following performance.

[0186] The fixing means inserted in the second endoscope, which isdifferent from the first endoscope attached the piercing device, canpull down body tissue while it is held and fixed reliably. The fixingmeans is brought into contact with the body tissue under observation bythe endoscope for easy operation and reduced time.

[0187] The first endoscope and the piercing device are providedseparately from the second endoscope and the fixing means. Therefore, anoperator can control the pull of the cardia or the position of theneedle entering point and form a valve of any shape according to thecondition of a particular patient.

[0188] The piercing device integrates two penetration needles. When thedistal end of the first endoscope attached the piercing deviceapproaches a penetration point on the esophageal wall, two needles areready to be penetrated. Treatment is simplified with reduced operationtime.

[0189] The piercing device makes the inner sheath touch the penetrationpoint before penetration. It makes it easy to locate the penetrationpoint and reliably penetrates toward the inside of the stomach throughthe esophagogastric junction. If a large valve is not required, it isformed without holding or fixing body tissue using the fixing means. Itfurther simplifies treatment and reduces operation time remarkably.

[0190] The piercing device has two penetration needles which areparallel and a certain distance apart from each other. Therefore, thetwo entering points or two exiting points should also be a certaindistance apart. As a result, an area of body tissue to be contracted bya suture cannot be too small. It is extended over a certain area andformed into a valve of desired size.

[0191] Two penetration needles are mounted at specified points on thecap at the distal end of the piercing device. Only by connecting the capto the distal end of the first endoscope can the two penetration needlesbe mounted at the specified points against the distal end of the firstendoscope. It reduces time for mounting them on the endoscope.

[0192] The piercing device or the fixing means is equipped with a meansfor pushing a knot of the suture. It eliminates preparing another knotpusher. Medical costs and preparation time are reduced.

[0193] Also the piercing device is inserted into a body lumen withoutdamaging it because the needles can be housed in the piercing device.

What is claimed is:
 1. A tissue-piercing device, to be used with anendoscope for suturing or ligating tissues in body cavities, which hastwo piercing members which have a needle respectively, said two needlesbeing in parallel and spaced apart at constant interval, furthercomprising two slideable suture-holding means which are slidablyinserted in each of said two needles and are extended from or retractedinto the distal ends of the needles; and holding-operation means foroperating the suture-holding means.
 2. A tissue-piercing device, to beused with an endoscope for suturing or ligating tissues in bodycavities, which has two piercing members which have a needlerespectively, said two needles being in parallel and spaced apart atconstant interval, wherein a suture is slidably fitted in each of saidtwo needles.
 3. A tissue-piercing device, to be used with an endoscopefor suturing or ligating tissues in body cavities, which has twopiercing members which have a needle respectively, said two needlesbeing in parallel and spaced apart at constant interval, furthercomprising slideable suture-holding means which is slideably inserted inone of said needles and is extended from or retracted into the distalends of said one of the needles; holding-operation means for operatingthe suture-holding means; and a suture slidably fitted in the other ofsaid two needles; wherein said suture-holding means being constructed tohold said suture.
 4. A treatment system, to be used with an endoscopefor suturing of ligating tissues in body cavities, comprising first andsecond endoscopes to be perorally inserted through body cavities; atissue-piercing device to be mounted to the first endoscope, which hastwo piercing members which have a needle respectively, said two needlesbeing in parallel and spaced apart at constant interval; a tissue-fixingdevice projecting from the distal end of the second endoscope for fixingthe site to be pierced; suture-holding means being slidably insertedthrough both needles of said tissue-piercing device, one of the needles,or the second endoscope; and a suture being slidably inserted throughboth needles of said tissue-piercing device, one of the needles, or thesecond endoscope.
 5. A tissue-piercing device according to claim 1 or 3,or a treatment system according to claim 4, said suture-holding meansbeing formed in loop; wherein a driving member for rotating, advancing,and retracting said suture-holding means is connected to the proximalend of said suture-holding means; and the center axis of saidsuture-holding means being inclined against the longitudinal axis ofsaid driving member.
 6. A tissue-piercing device, to be used with anendoscope for suturing or ligating tissues in body cavities, comprisingdelivery means for delivering a knot of the suture into the target sitein the human body and tightening it.
 7. A tissue-fixing device, to beused with an endoscope for suturing or ligating tissues in body cavitiesand fixing the tissue in piercing it, comprising delivery means fordelivering a knot of the suture into the target site in the human bodyand tightening it.
 8. A tissue-piercing device to be used with anendoscope for suturing or ligating tissues in body cavities, which hastwo piercing members which have a needle respectively, said two needlesbeing in parallel and spaced apart at constant interval, furthercomprising two slideable suture-holding portions which are slidablyinserted in each of said two needles and are extended from or retractedinto the distal ends of the needles; and a holding-operation portion foroperating the suture-holding portion.
 9. A tissue-piercing device, to beused with an endoscope for suturing or ligating tissues in bodycavities, which has two piercing members which have a needlerespectively, said two needles being in parallel and spaced apart atconstant interval further comprising a slideable suture-holding portionwhich is slidably inserted in one of said needles and is extended fromor retracted into the distal ends of said one of the needles; aholding-operation portion for operating the suture-holding portion; anda suture slidably fitted in the other of said two needles; wherein saidsuture-holding portion being constructed to hold said suture.
 10. Atreatment system to be used with an endoscope for suturing or ligatingtissues in body cavities, comprising first and second endoscopes to beperorally inserted through body cavities; a tissue-piercing device to bemounted to the first endoscope, which has two piercing members whichhave a needle respectively, said two needles being in parallel andspaced apart at constant interval; a tissue-fixing device projectingfrom the distal end of the second endoscope for fixing the site to bepierced; a suture-holding portion being slidably inserted through bothneedles of said tissue-piercing device, one of the needles, or thesecond endoscope; and a suture being slidably inserted through bothneedles of said tissue-piercing device, one of the needles, or thesecond endoscope.
 11. A tissue-piercing device according to claim 8 or9, or a treatment system according to claim 10, said suture-holdingportion being formed in loop; wherein a driving member for rotating,advancing, and retracting said suture-holding portion is connected tothe proximal end of said suture-holding portion; and the center axis ofsaid suture-holding portion being inclined against the longitudinal axisof said driving member.
 12. A tissue-piercing device, to be used with anendoscope for suturing or ligating tissues in body cavities, comprisinga delivery portion for delivering a knot of the suture into the targetsite in the human body and tightening it.
 13. A tissue-fixing device, tobe used with an endoscope for suturing or ligating tissues in bodycavities and fixing tissue in piercing, comprising a delivery portionfor delivering a knot of the suture into the targeting site in the humanbody and tightening it.